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Frontal Bone Window in ICUF (FBW-ICU) (FBW-ICU)

Primary Purpose

Acute Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial doppler examination
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Brain Injury focused on measuring Adults, Frontal bone window, Transcranial doppler

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Membership in a health insurance scheme
  • Patients with an acute cerebral pathology
  • Hospitalized patients in a supportive care unit of Montpellier University Hospital
  • Be able to benefit from transcranial doppler within 3 days of admission

Exclusion Criteria:

  • Clinical suspicion of encephalic death
  • Known allergy to ultrasound gel

Sites / Locations

  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Doppler examination

Arm Description

Transcranial Doppler examination

Outcomes

Primary Outcome Measures

measures of ACA flow velocities threw the frontal bone window

Secondary Outcome Measures

Full Information

First Posted
July 12, 2016
Last Updated
January 17, 2018
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02832895
Brief Title
Frontal Bone Window in ICUF (FBW-ICU)
Acronym
FBW-ICU
Official Title
Assessment of Frontal Bone Window for Transcranial Doppler Among Acute Brain Injured Patients in Intensive Care Units: a Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Conducting an interim analysis that allowed with the number of patients included of 150 to meet the objectives of this research
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to detect a segmental lesion on the anterior cerebral arteries (ACA). The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA. However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not been yet determined. The goal of the present study is to determine the rate of detection of the ACA by using the FBW in patients with ABI in ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injury
Keywords
Adults, Frontal bone window, Transcranial doppler

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Doppler examination
Arm Type
Experimental
Arm Description
Transcranial Doppler examination
Intervention Type
Other
Intervention Name(s)
Transcranial doppler examination
Intervention Description
Assessment of frontal bone window for transcranial doppler
Primary Outcome Measure Information:
Title
measures of ACA flow velocities threw the frontal bone window
Time Frame
up to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Membership in a health insurance scheme Patients with an acute cerebral pathology Hospitalized patients in a supportive care unit of Montpellier University Hospital Be able to benefit from transcranial doppler within 3 days of admission Exclusion Criteria: Clinical suspicion of encephalic death Known allergy to ultrasound gel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille CM Maury, MD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Frontal Bone Window in ICUF (FBW-ICU)

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